Kornimate/medical-research-clean huggingface dataset:
validation of a frailty self assessment tool

Conditions: Frailty

Summary: the number of elderly is increasing throughout of the world. aging is associated with increasing diseases that may be preventable. over the last decades, frailty has emerged as one of the major risk factors for loss of autonomy. frailty can be reversed through appropriate interventions particularly when they are implemented early. therefore, early detection of frailty is a major objective. the goal of this study is to identify elderly subjects aged 70 years and over at the early stage of frailty by using a self administered questionnaire sent to the participant by mail. the results of the self assessment will be compared to the fried criteria collected by a clinical examination conducted by a healthcare professional blinded to the self assessment results.

five thousands (5000) retirees aged 70 and over will be randomly selected from national retirement pension institute (cnav) retirees (2500 living in paris and 2500 living in toulouse). they will receive a letter from the cnav explaining the study approach and a separate self-assessment frailty questionnaire to be filled in by the retirees at home and sent back in a pre-paid envelope to international longevity centre france (ilc-france). retirees who have accepted the home assessment are examined by a healthcare professional, blinded to the results of self-administered questionnaire, using the fried's frailty criteria in order to confirm or infirm the diagnosis of frailty. the general practitioner will be informed of the investigation results in order to set up a personalized prevention plan. ilc-france will anonymize both the self-administered questionnaires and the fried assessments and send them to the mixed research unit (umr) 1027 in toulouse. comparison of the fried assessment results with those of the self-questionnaire will confirm the metrological characteristics (false negative, false positive, sensitivity, specificity, predictive value) of the questionnaire. secondary analyses will be conducted to compare the prevalence of frailty by age and gender. the statistical analysis is carried out by the umr 1027 of toulouse.

Eligibility criteria:
inclusion criteria: * retirees from the national old-age insurance fund * aged 70 or older, * living at home * representatives of the general population exclusion criteria: * institutionalized retirees * retirees receiving the personalised allowance for autonomy * retirees who enrolled in previous studies
pharmacogenetics of hypertriglyceridemia in hispanics

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertriglyceridemia

Summary: to study the effect of genes on lipid-lowering drug treatment in hypertriglyceridemia.

background: increased serum triglycerides are a significant independent risk factor for coronary artery disease and myocardial infarction. besides typical lifestyle modification, the treatment with fibrates is standard in patients with hypertriglyceridemia. there is ample evidence that genetic factors influence triglyceride levels. identifying genes, which affect triglyceride levels and moreover determining the response to fibrates is of great interest. hispanics are among the populations with the highest prevalence of this disease. therefore focusing on a high-risk population further adds to the overall significance of this study. identifying genes and genetic mechanisms contributing to the treatment response can lead to new or improved treatment methods. design narrative: the study tests the hypothesis that differences in therapeutic effects of fibrates are related to variations in networks of genes regulating lipoprotein metabolism. an efficient approach for identifying and categorizing major gene variants is based on determination of sequence haplotypes. only hispanics will be studied to provide a homogenous population for this genetic study. furthermore, hispanics are the fastest growing ethnic group in the u.s. and have a higher prevalence of hypertriglyceridemia than other ethnic groups. the investigators will measure plasma triglycerides (tg), other lipids and lipoproteins, and lipoprotein particle size before and after treatment with fenofibrate in 800 hispanic individuals with hypertriglyceridemia. they will reconstruct the haplotypes of 16 candidate genes known to regulate tg metabolism and mediate the effect of fibrates. the associations between phenotypes and major haplotypes will be analyzed in a two stage design, with the first half of the sample serving a hypothesis-generating function. those candidate gene haplotypes that are found to be associated with quantitative traits and drug responses in the first half of the sample will then be tested for confirmation in the second half. in addition, data from the full cohort will be analyzed to identify additional pharmacogenetic associations that may require greater statistical power. finally, direct fine mapping will be performed in the four most promising genes to identify the responsible variations.

Eligibility criteria:
hispanics with hypertriglyceridemia
effect of eradication of helicobacter pylori on the dyspeptic symptoms

Conditions: Functional Dyspepsia; Helicobacter Pylori Infection

Summary: helicobacter pylori eradication and its impact on symptoms in patients with non-ulcer dyspepsia remain controversial . many studies have examined the effect of h. pylori eradication on dyspeptic symptoms, but the results have been conflicting and inconclusive, with as many studies yielding positive as negative results. some studies have shown a significant (although weak) symptomatic improvement after h. pylori eradication, and while other yielding negative results. a recent cochrane review has comprehensively demonstrated that h.pylori eradication therapy has a small but statistically significant effect in h.pylori positive non-ulcer dyspepsia. an economic model suggests this modest benefit may still be cost effective . however it is difficult to reconcile these results in areas with very high prevalence of h. pylori infection such as pakistan since no such studies have been conducted in developing countries. the investigators hypothesize that eradication of helicobacter pylori (h. pylori) leads to a sustained improvement in symptoms of patients diagnosed with h. pylori associated functional (non-ulcer) dyspepsia.


Eligibility criteria:
inclusion criteria: * ambulatory adult males and non-pregnant females. * dyspeptic symptoms for at least 3 months. * normal endoscopic findings. * h. pylori positive on testing. exclusion criteria: * patients with erosive and non erosive esophagitis. * barrette's esophagus. * duodenal ulcer, gastric ulcer or gastric erosions. * patients with known sensitivity to antibiotics. * patients with severe concomitant systemic disease. * patients with upper gi surgery except cholecystectomy. * females with pregnancy or breast-feeding. * malignancy * alarm symptoms such as bleeding per rectum, hematemesis, and severe weight loss.

Keywords: functional dyspepsia helicobacter pylori eradication quality of life dyspeptic symptoms
cerebellar neuromodulation to enhance fear extinction and predict response to exposure therapy

Conditions: Anxiety Disorders; Social Phobia

Summary: emerging neuroimaging studies have shown that the cerebellum contributes to different aspects of timing, prediction, learning, and extinction of conditioned responses to aversive stimuli, factors that may be relevant to the success of exposure based behavioral therapy. our goals are to determine the cerebellar contributions to fear extinction by attempting to modulate key pathways in this process by theta burst stimulation. the long term goal is to lay the foundation for future studies in which neuromodulation is used to augment exposure therapy.

participants in this study will undergo an assessment for past history and present symptoms of mood, anxiety, trauma, substance abuse, and eating disorders. safety screening for functional mri (fmri) and repetitive transcranial magnetic stimulation (rtms) will be performed prior to enrollment. phase 1 of the study involves two visits. the first visit involves undergoing an fmri scan and a motor thresholding procedure for rtms. a clinical assessment will be performed for the above symptoms, or a recap of symptoms if the participant had been previously assessed at our institute. the second visit involves a fear conditioning session performed in the fmri scanner followed by one session of rtms over either a cerebellar or occipital lobe (control) target. this will be immediately followed by a fear extinction phase, also in the fmri scanner. the participant will return in 24hours to determine consolidation of the fear extinction process. phase 2 is similar to phase 1, except that each participant will undergo two sessions of the fear conditioning and fear extinction phases while undergoing an fmri scan. in one session, they will receive rtms over a cerebellar target. in the other session, they will receive rtms over a control site. these sessions will be separated by at least 1 week. the participants will then undergo 10 weeks of exposure therapy for social phobia. the goal is to determine whether neuroplasticity related to cerebellar stimulation can predict the response to exposure therapy.

Eligibility criteria:
inclusion criteria: * generalize anxiety or social phobia with an oasis score =\>8 exclusion criteria: * safety concerns related to undergoing an fmri scan or tdcs, such as metal in the head, history of unprovoked seizures in self or a first-degree family member, medications that reduce seizure threshold, pregnant or planning to become pregnant. * history of post traumatic stress disorder, obsessive compulsive disorder, panic disorder, current major depressive illness, substance abuse in the past 1-year, or any thought disorder such as schizophrenia or bipolar disorder.

Keywords: social phobia anxiety cerebellum tdcs neuromodulation fear extinction
growth hormone in a patient with a dominant-negative ghr mutation

Conditions: Growth Disorders

Summary: this is a prospective interventional study designed for a single patient with a dominant-negative mutation in the growth hormone receptor gene (ghr) which results in increased levels of growth hormone binding protein (ghbp). the patient will receive escalating doses of growth hormone titrated to achieve an insulin like growth factor-1 level above the mean and then growth response to therapy will be monitored.


Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. be the specific subject with the a specific mutation in ghr leading to high ghbp. exclusion criteria: there are no exclusion criteria for this study.
growth, tolerance, and safety study of healthy term infants consuming a new organic cow's milk-based infant formula

Conditions: Healthy Growth

Summary: the goal of this study is to demonstrate that healthy term babies who are fed bobbie's study formula grow at the same rate as those fed with an existing cow's milk formula. breastfeeding is the ultimate reference for infant nutrition. therefore, this study also includes a group of breastfed babies for additional comparison.

this is a 16 week, double-blind, randomized, controlled trial designed to demonstrate that a new infant formula for term infants supports age-appropriate growth. the study has been designed in accordance with good clinical practice guidelines and the requirements of the code of federal regulations 21 cfr 106.96

Eligibility criteria:
inclusion criteria: * healthy gestational term (≥ 37 wks; ≤ 41 wks and 6 days) * birth weight of ≥ 2,500 g and ≤ 4,500 g * postnatal age ≤ 11 days at time of enrollment * singleton * caregiver who has previously decided to exclusively feed infant formula or exclusively breastfeed and is willing to continue with current feeding method throughout the study (breastfeeding or formula feeding) * caregiver willing to conform to protocol requirements (e.g. measuring, feeding, completion of food intake and tolerance diaries, reporting of aes, and urine collection) * caregiver willing and able to sign irb approved informed consent exclusion criteria: * infant born with medical complications (e.g., neurological, cerebral palsy, etc.) * infant with failure to thrive, fever, any gi tract abnormalities (e.g., short gut, gastroesophageal reflux, etc.), any congenital illness or malformation that may affect infant feeding or normal growth * maternal, fetal, or infant medical history thought to have an impact on growth and/or development (substance abuse, positive hiv status, opioid exposure, or diabetes requiring insulin) * infant receiving prescription medication * infant with a known history of cow's milk protein allergy, excluding lactose intolerance * infant who has been treated with antibiotics or medications that may impact growth, gi tolerance and/or development * infant or family history (grandparent, parent, sibling) with known folate metabolism disorder * caregiver intent to feed non-study formula or solid food during the study

Keywords: organic bobbie bobbie baby weight growth breastfeeding infant formula growth and tolerance
short course glucocorticoid treatment for ptsd

Conditions: Post-traumatic Stress Disorder

Summary: the purpose of this study is to investigate if a 2-wk course of 20mg/day of oral prednisone in addition to standard care will result in reduced ptsd symptoms or symptom severity compared to placebo


Eligibility criteria:
inclusion criteria: * must meet diagnostic and statistical manual of mental disorders (dsm-iv) criteria for ptsd w/ symptom exacerbation (caps score ≥ 50) * stable on other psychotropic meds x1 month exclusion criteria: * current or past history of bipolar, schizophrenic, or other psychotic disorder * organic mental disorder * alcohol or substance abuse in last 3 months * clinically significant hepatic or renal disease or other acute or unstable medical condition * chronic obstructive pulmonary disease (copd), asthma, uncontrolled diabetes, rheumatologic diseases
prostatic urethral lift in subject with acute urinary retention

Conditions: Acute Urinary Retention; Benign Prostatic Hyperplasia

Summary: assess feasibility and safety of the prostatic urethra lift (pul) procedure in patients with acute urinary retention secondary to benign prostatic hyperplasia (bph).

the study is a multi-centre, prospective evaluation of pul and retrospective review of invasive surgery as potential comparator. the study is intended to be conducted at up to 5 different centres in the united kingdom to enrol up to 50 subjects. subject follow-up visits are at post-procedure, 6 weeks, 3 months, 6 months and 12 months.

Eligibility criteria:
urolift system procedure arm inclusion criteria: 1. male gender 2. diagnosis of symptomatic bph 3. age ≥ 50 years 4. prostate volume ≤ 100 cc per ultrasound (us) 5. acute urinary retention with at least one failed trial without catheter (twoc) while on alpha blocker exclusion criteria: 1. an obstructive or protruding median lobe of the prostate 2. previous bph surgical procedure 3. previous pelvic surgery 4. urethral conditions that prevents insertion and delivery of device system into bladder 5. retention volume of \>1500 ml 6. has not had prostate cancer excluded 7. history of prostate or bladder cancer 8. biopsy of the prostate within the 6 weeks prior to index procedure 9. history of neurogenic or atonic bladder 10. acute or chronic renal failure 11. known coagulopathies or subject on anticoagulants within 3 days of index procedure (excluding up to 100mg asa) 12. known bladder stones within the prior 3 months or treatment within 12 months 13. prostatitis requiring treatment (antibiotics) within the last year 14. other co-morbidities that could impact the study results * severe cardiac arrhythmias uncontrolled by medications or pacemaker * congestive heart failure new york heart association (nyha) iii or iv * history of uncontrolled diabetes mellitus * significant respiratory disease in which hospitalisation may be required * known immunosuppression (i.e. aids, post-transplant, undergoing chemotherapy) 15. life expectancy estimated to be less than 5 years 16. desire to maintain fertility post procedure 17. unable or unwilling to complete all required questionnaires and follow up assessments 18. unable or unwilling to sign informed consent form 19. currently enroled in any other clinical research trial that has not completed the primary endpoint

Keywords: benign prostatic hyperplasia bph urinary retention prostate hypertrophy
effects of mulligan's mobilization with and without clamshell exercises in sacroiliac joint dysfunction

Conditions: Sacroiliac Joint Somatic Dysfunction; Pain; Disability Physical; Treatment

Summary: sacroiliac joint dysfunction is the changing of joint structure (ligaments, muscles and cartilage) that cause impairments and movement restrictions. it is one of the primary sources of low back pain among female population and often misdiagnosed. almost 15-30% patients are suffering from sacroiliac joint dysfunction who presented with the complaint of low back pain. the aim of the study is to determine the effect of mulligan's mobilization with and without clamshell exercise on pain, disability and quality of life in patients with sacroiliac joint dysfunction.

a randomized controlled trial will be conducted at fatima memorial hospital physiotherapy clinic \& boston physiotherapy and wellness clinic through consecutive sampling technique on 32 patients which will be allocated through simple random sampling through sealed opaque enveloped into group a \& group b. group a will be treated with only mulligan's mobilization with movement at the frequency of 3 sets with 10 repetitions 3 times/ week without the clamshell exercise. group b will be treated with mulligan's mobilization with movement and clamshell exercises. outcome measures will be conducted through pain, disability and quality of life questionnaire after 6 weeks. data will be analyzed during spss software version 21. after assessing normality of data by shapiro wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Eligibility criteria:
inclusion criteria: * male and female between the ages of 20 to 50 years with positive leslett's criteria. * sacroiliac pain of sub-acute level with the duration of 4 weeks exclusion criteria: * spondylosis * lumbar canal stenosis * spondylolisthesis * pervious spinal surgery * congenital postural deformities and * lumbar disc herniation * pelvic bone fractures
comparison of neuromuscular blockade's monitoring and clinical assessment during cisatracurium paralysis in critically ill patients

Conditions: Critical Illness

Summary: the main objectives of the prolonged resuscitation paralysis are usually adaptation to mechanical ventilation, lower insufflation pressures and cough suppression. the use of monitoring during the prolonged neuromuscular blockade is the subject of recommendations. its interest is subject to a recommendation grade b and its use in prevention of overdose is associated with a recommendation of grade c. however, many practitioners continue to objectify the depth of neuromuscular blockade and reversal by simple clinical evaluation. this is a subjective estimate of the depth of neuromuscular block. resuscitation in several pharmacokinetic parameters are taken into account. first, the drug distribution volume is usually increased in the intensive care patient and requires an increase in initial doses to obtain the same pharmacological effect. then, unlike a short-term administration, the administration of neuromuscular blocking agents on days causes diffusion in peripheral compartments. their diffusion coefficients are slower which contributes to the increase of the elimination period after interruption of the administration of curare. there is therefore a risk of residual paralysis. secondarily, the curare needs can be influenced by thermoregulation, water and electrolyte disorders and acid-base, administration of certain drugs, the inter- and intra-individual variability and tachyphylaxis (form tolerance of particularly rapid installation during a few close administration, linked to the proliferation of cholinergic receptors). the value of monitoring neuromuscular blockade in intensive care is the prevention of overdose and in finding the lowest effective dose.


Eligibility criteria:
inclusion criteria: * age over 18 years * mechanically ventilated patients * indication for prescribing curare extended less than 1 day * sedation * information form waived by family members or surrogates exclusion criteria: * pregnancy, * curare infusion ongoing * neuromuscular disorders * dermal alteration * allergy to cisatracurium, atracurium, benzene sulfonic acid * expected survival of less than 2 days * personal or family history of malignant hyperthermia * no social security * patient under enhanced protection * patient participating to an other intervention research or participated within 30 days

Keywords: efficient neuromuscular blockade
clockwork postpartum weight management study

Conditions: Obesity; Postpartum Weight Retention; Weight Gain, Maternal

Summary: the clockwork postpartum weight management pilot study is an intervention study that will assess the feasibility, acceptability, and initial efficacy of the clockwork intervention among women with prepregnancy overweight/obesity during the first 4 months postpartum.

overview of procedures. the investigators developed a prototype mobile app to monitor clockwork target behaviors, and now aim to gain stakeholder input to refine the interface and improve usability via feedback from postpartum women who began pregnancy with obesity. in this pilot trial, women will complete baseline assessments in the first month postpartum and be randomized to either usual care or clockwork for 4 months, then complete assessments. participants \& recruitment. given that the investigators want to initiate treatment quickly after delivery, women will be recruited at the end of pregnancy through magee-womens hospital. women will be randomized to receive either the clockwork intervention or usual care. clockwork is a behavioral weight loss intervention comprised of coaching sessions as well as digital monitoring and feedback tools. it addresses 4 key behaviors related to the circadian timing system (cts), weight, and health and their amount, regularity \& timing-the art of clockwork. women will receive 12 tailored coaching sessions to review digital monitoring of each key behavior, learn intervention content, and set goals, which are delivered in-person, by phone, or web to fit women's needs postpartum. coaches (dr. kolko conlon or study interventionist) will use women's baseline responses to tailor sessions around the key behaviors. the investigators will protocolize real-time monitoring to increase engagement and adherence, and to facilitate just-in-time adaptive reminders, recommendations, and coaching sessions. usual care does not involve any additional intervention.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * prenatal bmi greater than or equal to 25 * at least 28 weeks gestation * english speaking * singleton pregnancy exclusion criteria: * preexisting diabetes * use of medications known to affect weight (example, second generation antipsychotics) * enrolled in current weight management programming * recent weight loss surgery (within the past 3 years) * women who endorse acute psychiatric symptoms (e.g., suicidality) that warrant immediate treatment will be excluded and referred for care.